Thomas Breuer and colleagues at GlaxoSmithKline respond to Peter DoshiBMJ 2018; 363 doi: https://doi.org/10.1136/bmj.k4116 (Published 03 October 2018) Cite this as: BMJ 2018;363:k4116
- Thomas Breuer, senior vice president, chief medical officer,
- Vincent Bauchau, director, clinical safety and pharmacovigilance,
- Tatjana Poplazarova, vice president, head of medical governance, bioethics and scientific publications,
- Jens-Ulrich Stegmann, vice president, head of clinical safety and pharmacovigilance
- GSK Vaccines, 20 Avenue Fleming, 1300 Wavre, Belgium
We are writing to respond to The BMJ’s feature article about the Pandemrix vaccine.”1 Our response focuses on some of the statements in the article as well the methodology on which the major premise of the article is based.
The statement by The BMJ that the available safety data were not disclosed to the public by the authorities or by GlaxoSmithKline is incorrect. During the pandemic, safety data available to GSK and the company’s analyses of those data were shared regularly with the authorities through weekly teleconferences and monthly written periodic safety update reports. Summaries of the information relating to all pandemic vaccines used in Europe were made available to the public weekly on the European …